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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20181354 | Other Identifier | National Medical Products Administration |
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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
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To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Participants with relapsed/refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma can participate if all eligibility criteria are met.Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws.Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human CD19 targeted T Cells Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human CD19 targeted T Cells Injection | Drug | Autologous genetically modified anti-CD19 CAR transduced T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 | 2 years post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of CAR-positive T cells in circulation | 2 years post infusion | |
| Total number of CAR-positive T cells infiltrated into lymphoma tissue | 2 years post infusion | |
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Inclusion Criteria:
Male or female subjects with CD19+ B cell lymphomas who have a limited prognosis (several months to <2 year survival) with currently available therapies will be enrolled.
18 to 70 Years Old, Male and female;
Expected survival > 12 weeks;
Clinical performance status of ECOG score 0-1;
Pathology demonstrated that CD19-positive B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:
It can establish the venous access required for collection, satisfying hemoglobin ≥ 70 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L. Mononuclear cell collection can be determined by the investigators;
At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria;
Liver, kidney and cardiopulmonary functions meet the following requirements:
Able to understand and sign the Informed Consent Document.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongliang Fang, Dr. | Contact | 021-58552006 | fanghongliang@dashengbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36536403 | Derived | Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6. | |
| 34515338 | Derived |
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| Overall remission rate including complete response and Partial response defined by the standard response criteria for malignant lymphoma. |
| 90 days post infusion |
| Duration of Response after administration | 90 days post infusion |
| Progress Free Survival after administration | 90 days post infusion |
| Overall Survival after administration | 90 days post infusion |
| The immunogenicity of Human CD19 targeted T Cells Injection. (HAMA detection of human anti-mouse antibody) | 2 years post infusion |
| Fudan University Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| The First Affilicated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325003 | China |
|
| Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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